Medizintechnik - AHK Korea

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approved product. For these two categories,
the MFDS requires submission of detailed
technical documentation including clinical
evaluation.
The revised MDA provides for stricter approval
standards for Class III (i.e. devices that
impose a moderate risk to public health)
and Class IV medical devices (i.e. devices
that impose a high risk to public health).
To illustrate, the MFDS requires a technical
document review for all Class III and Class IV
products, although the required information
may vary depending on their level of equivalency
with previously approved products.
Attention is drawn to the recently introduced
Summary Technical Documentation
(STED), which will come into effect in
January 2014. Applicants for Class IV medical
devices (excluding IVD reagent) will be
required to submit the STED while those
who apply for other Classes may choose to
submit the STED. STED provides for a fast
track technical review.
Also, under the amended MDA, foreign
testing is now more widely accepted during
the approval process in an attempt to implement
international standards and the speci-
fic requirements of the EU-Korea FTA.
KGMP Certification
All Class II, III and IV now require a KGMP
compliance audit. At the same time, the
number of product categories for which a
KGMP audit is required has been reduced
from 39 to 26.
In the case of a foreign medical device
manufacturer, the local importer must submit
the application for the KGMP Certificate.
Previously, foreign manufacturers could
automatically obtain a KGMP Certificate if
the domestic importer was holder of a Korea
Good Import Practice (KGIP), which is no
longer available under the new rules.
On-site inspections at the premises of the
foreign manufacturer are now mandatory
for Class III and IV Devices and will also be
required for Class II starting from 2014.
Device Business License
The device business license is available
for five business categories, which include
manufacturing, importing, refurbishing,
distributing, and rental business. The application
for device business license is submitted
to MFDS when a medical devices
manufacturer that is new to the Korean
market applies for the final device approval
or notification. A domestic importer typically
would have a device business license already
in place for other products.
Summary and Outlook
Upon completion of the pre-market registration
process described above, a medical
device can be finally imported to Korea.
Manufacturers and importers must, however,
comply with a number of important
post-market surveillance requirements once
the product is on the market. These include
medical device tracking, adverse event &
safety alert reporting, product recall, as well
as product re-evaluation. The MFDS can
monitor the due adherence to these requirements
through onsite inspections and field
audits.
Ki Young Kim is a partner at Yulchon
LLC leading its Healthcare Practice Team.
German qualified Rechtsanwalt Moritz
Winkler heads the firm’s German Desk.
KORUM Nr. 48 | Dezember 2013 25